CDISC Data Assembly Services.

The FDA has published in December 2014 the binding guidance documents requiring the submission of study data in electronic format, the conversion of clinical data to the appropriate FDA-supported data standard becomes a high priority. The submission of standardized study data enhances a reviewer’s ability to more fully understand and characterize the efficacy and safety of the drug, and complements and promotes interactions between FDA reviewers, sponsors, and data providers.

Cognigen data programmers have extensive clinical data management knowledge and experience converting PK-related data into the CDISC SDTM and ADaM standard formats required by the FDA, including SDTM domains PC, PP, DM, EX, their respective supplemental domains, and ADaM basic data structures such as ADPC and ADPP. Cognigen stays current with all data standards, and is also involved with developing new CDISC data standards.

Susanne Sardella, Associate Director of Data Management at Cognigen, is a member of the CDISC ADaM PK Standards Development team. According to Sardella, “Currently, SDTM standards exist for the derived pharmacokinetic parameter (PP) results, but there is no standard for the noncompartmental analysis dataset that the parameters are based on. The goal of the ADaM PK development team is to provide a basic data structure for these analysis datasets that facilitates common statistical analysis methods, and allows for the necessary traceability and transparency between other SDTM / input data and noncompartmental analysis."

Cognigen takes pride in its comprehensive preparation and efficient process for converting data to CDISC standards. Policies and procedures are in place to ensure quality of deliverables, and the data programmers have a toolkit full of macros, templates, and snippets to facilitate the conversion time and ensure the validation of the results.

We would be happy to speak with you in more detail about our CDISC Services—call us at +1.716.633.3463 or Send us a note.